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Lifestyle Modification for Obesity-Related Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00415688
Recruitment Status : Completed
First Posted : December 25, 2006
Last Update Posted : December 25, 2006
Information provided by:
Robert C. Atkins Foundation

Brief Summary:
Dietary carbohydrate is the major determinant of postprandial glucose levels, and preliminary evidence suggests that low carbohydrate diets improve glycemic control when accompanied by weight loss. To determine if glycemic control can be improved by varying dietary carbohydrate during weight loss, we compared two weight loss diets with different carbohydrate levels for the treatment of obesity-related type 2 diabetes over 24 weeks in the outpatient setting.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Overweight Obesity Behavioral: Low carbohydrate, ketogenic diet Behavioral: Low glycemic index, reduced calorie diet Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial of a Low-Carbohydrate, Ketogenic Diet Versus a Low-Glycemic Index Diet for Obesity-Related Type 2 Diabetes
Study Start Date : July 2004
Estimated Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Hemoglobin A1c

Secondary Outcome Measures :
  1. Body weight
  2. Serum lipoproteins

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • type 2 diabetes mellitus for at least one year
  • hgba1c > 6.0
  • BMI from 27-50 kg/m2

Exclusion Criteria:

  • Unstable medical condition
  • Serious medical condition
  • AST or ALT > 100
  • Serum creatinine > 1.5

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00415688

United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27704
Sponsors and Collaborators
Robert C. Atkins Foundation
Principal Investigator: Eric C Westman, MD MHS Duke University Health System Identifier: NCT00415688     History of Changes
Other Study ID Numbers: AF001
First Posted: December 25, 2006    Key Record Dates
Last Update Posted: December 25, 2006
Last Verified: December 2006

Keywords provided by Robert C. Atkins Foundation:
lifestyle modification
weight loss
hypoglycemic agents

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms